In large abdominal incisions, successful closure often requires in addition to skin sutures at the exposed outer layers, the use of transverse tension sutures, usually designated stay or retention sutures, which are relatively large loops that extend down through both sides of and under an incision, and extend over and are tied across the closure. Such retention sutures pass through numerous layers of tissue, such as fascia, fat and muscle, and are tied tightly to help position and join each layer to its appropriate counterpart and to hold these severed tissues in proper juxtaposition. After closure the incision area usually has certain swelling owing to edema caused by the physical and chemical trauma of surgery, thus causing tightening of the sutures. Internal or external body movement or muscular strain is likely to place additional tension in the sutures.
In the typical cases where the sutures are in contact with the skin under them, the strain and swelling results in increased suture tension, with the suture impressing itself deeply into the skin causing redness of erythema, infection which slows or otherwise impairs healing, necrosis of tissue cells and/or increased scarring and cross-hatching, sometimes called railroad scarring.
Various techniques and devices have been used in attempts to obviate these problems. Initial attempts involved loose tying of sutures to allow for swelling, but this left the incision not securely closed. According to one current and widely used technique a section of rubber catheter tubing is cut to a length generally the same as the distance between the exit points of the suture from the skin on either side of an incision. One of the two exposed portions of each suture is threaded through the bore of a section of catheter and tied to the other portion. This technique of using catheter sections has the disadvantage of failing to maintain lateral fixation of the portions of the retention suture at the exit points, because the flexible tubing bends or buckles; also with such catheter sections the above-mentioned problem of pressure necrosis remains, due to pressure contact of the tube along its length against the skin and particularly at the exit points.
Rigid tubes of fixed and varying length have been used; however, along their length they also bear upon the skin surface, causing cross-hatch scarring of considerable extent. Flat pieces of wood, metal and plastic of fixed length with notches in opposite ends have also been employed, but these have the same disadvantages as rigid tubing. Further description of prior art as generally relates to retention sutures may be found in U.S. Pat. No. 3,695,271, which discloses a retention suture bridge comprising a resilient, single piece arch whose ends are formed as continguous and fixed feet. This device has been used to support the exposed portion of the retention suture off and above the the wound; however in use an unexpected problem occurred, namely tipping of the arch from its initially upright orientation. This was due to a variety of causes including, excessive tension in the suture either when tied or after swelling of the incision area, change of stomach contours when a patient sat up or turned, or swelling of the tissue under one side of one or both feet. Any such tipping of the arch necessarily and simultaneously tipped the bridge feet; also tipping of one foot simultaneously tipped the other foot. Where a foot tipped, the tipped arch could then be lying against the incision and thus no longer function exactly as intended; where the arch tipped the side edges of the connected foot could press into adjacent skin leading to bruising and discomfort. The present invention is concerned particularly with an improvement over the device disclosed and claimed in this U.S. Pat. No. 3,695,271.
The objectives of the present invention extend considerably beyond those in the above-cited patent, and are now accomplished with a new and significantly different retention suture bridge device. The various objectives include provision of a device for maintaining the exposed portion of a retention suture above and out of contact with the incision closure area, while the device itself has minimal or no pressure contact with this area. It is a further objective to maintain lateral fixation of the suture exit points and thereby to stabilize the area of the joined tissues and prevent separation of the joined tissues. The new device should readily accommodate retention sutures having a variety of distances between suture and exit points, without irritation of the skin at these exit points.
An additional objective is to provide a device which conforms well to the contours of a typical abdomen where retention sutures are most commonly used, and which remains secure and properly oriented relative to the engaged retention suture and the incision closure area, even when the patient moves or bends or when the skin of the incision area under a foot part of the device or under the arch becomes swollen or otherwise distorted. More specifically the new device overcomes the problems where movement by a patient or swelling of the incision area tips the device about its longitudinal axis, causing the side of the arch portion or of a foot portion to contact and/or press against adjacent skin, or to pull the tied retention suture more tightly than should be experienced. The new invention achieves substantially all of the above-discussed objectives with a structure that is simple yet reliable, as described in the following paragraphs.